TABLE 4

Number of participants reporting adverse eventsd

AENo. (%) of participants reporting AEs with the following treatment:
Test (DTG-RPV FDC tablet) (n = 115)Reference (DTG and RPV separate tablets) (n = 116)
Any AE20 (17)21 (18)
AEs reported in ≥2 participants in either treatment group
    Headache5 (4)2 (2)
    Upper respiratory infection2 (2)1 (<1)
    Contact dermatitis1 (<1)2 (2)
    Arthropod bitea2 (2)0
Any drug-related AE5 (4)3 (3)
    Headache4 (3)2 (2)
    Diarrhea1 (<1)0
    Catheter-site swellingb01 (<1)
    Decreased appetite1 (<1)0
AEs leading to discontinuation of study drug1 (<1)c0
  • a A spider bite that became a localized methicillin-resistant Staphylococcus aureus infection.

  • b Related to study procedures and not a study drug.

  • c Grade 2 bronchitis on day 2 postdose; the bronchitis resolved 27 days after onset and was considered nonserious, moderate, and not related to the investigational product. The participant did not receive study drug in period 2 and was withdrawn from the study on day 36 by physician decision.

  • d AE, adverse event; DTG, dolutegravir, FDC, fixed-dose combination; RPV, rilpivirine.